A Study of Obinutuzumab, Polatuzumab Vedotin, and Lenalidomide in Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab in Combination With Polatuzumab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
18 Years and older, Male and Female
NCT02600897 (primary)
2015-001999-22
GO29834
Summary
This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment
with obinutuzumab, polatuzumab vedotin, and lenalidomide in participants with relapsed or
refractory (R/R) follicular lymphoma (FL) and rituximab in combination with polatuzumab
vedotin and lenalidomide in participants with R/R diffuse large B-cell lymphoma (DLBCL),
followed by post-induction treatment with obinutuzumab in combination with lenalidomide in
participants with FL who achieve a complete response (CR), partial response (PR), or stable
disease (SD) at end of induction (EOI) and post-induction treatment with rituximab plus
lenalidomide in participants with DLBCL who achieve a CR or PR at EOI.
Objectives
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Percentage of participants with CR, determined by an independent review committee (IRC) on the basis of positron emission tomography (PET) and computed tomography (CT) scans [ Time Frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) ] [ Designated as safety issue: No ] |
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Same as current |
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Complete list of historical versions of study NCT02600897 on ClinicalTrials.gov Archive Site |
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Percentage of participants with adverse events [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
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Percentage of participants with dose-limiting toxicities (DLTs) [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: Yes ]
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Percentage of participants with CR, determined by the investigator on the basis of PET and CT scans [ Time Frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) ] [ Designated as safety issue: No ]
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Percentage of participants with CR, determined by the investigator on the basis of CT scans alone [ Time Frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) ] [ Designated as safety issue: No ]
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Percentage of participants with objective response, determined by an IRC on the basis of PET and CT scans [ Time Frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) ] [ Designated as safety issue: No ]
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Percentage of participants with objective response, determined by the investigator on the basis of PET and CT scans [ Time Frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) ] [ Designated as safety issue: No ]
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Percentage of participants with objective response, determined by an IRC on the basis of CT scans alone [ Time Frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) ] [ Designated as safety issue: No ]
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Percentage of participants with objective response, determined by the investigator on the basis of CT scans alone [ Time Frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) ] [ Designated as safety issue: No ]
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Observed serum obinutuzumab concentration [ Time Frame: Pre-dose and/or 30 minutes post-dose on Day 1 of Cycles 1, 2, 4, and 6 during induction; pre-dose on Day 1 of Months 1, 7, 13, and/or 19 during the post-induction phase; then up to 2 years after last dose as available (maximum 5 years) ] [ Designated as safety issue: No ]
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Observed serum and plasma polatuzumab vedotin concentration [ Time Frame: Pre-dose and/or 30 minutes post-dose on Days 1, 8, and 15 of Cycle 1; pre-dose and/or 30 minutes post-dose on Day 1 of Cycles 2, 4, and 6 during induction; then up to 2 years after last dose as available (maximum 5 years) ] [ Designated as safety issue: No ]
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Observed plasma lenalidomide concentration [ Time Frame: Pre-dose and/or 0.5, 1, 2, 4, and 8 hours post-dose on Days 1 and 15 of Cycle 1 and on Day 1 of Cycle 6 (maximum 5 years) ] [ Designated as safety issue: No ]
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Percentage of participants with human anti-human antibodies (HAHAs) to obinutuzumab [ Time Frame: Pre-dose on Day 1 of Cycles 1 and 6 during induction; then up to 2 years after last dose as available (maximum 5 years) ] [ Designated as safety issue: No ]
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Percentage of participants with anti-therapeutic antibodies (ATAs) to polatuzumab vedotin [ Time Frame: Pre-dose on Day 1 of Cycles 1, 2, and 4 during induction; then up to 2 years after last dose as available (maximum 5 years) ] [ Designated as safety issue: No ]
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Same as current |
Eligibility
- Age greater than or equal to (>/=) 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- For obinutuzumab in combination with polatuzumab vedotin and lenalidomide (G + Pola + Len) treatment group: R/R FL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody and for which no other more appropriate treatment option exists as determined by the investigator
- For rituximab in combination with polatuzumab vedotin and lenalidomide (R + Pola + Len) treatment group: R/R DLBCL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody in patients who are not eligible for autologous stem-cell transplantation or who have experienced disease progression following treatment with high-dose chemotherapy plus autologous stem-cell transplantation
- Histologically documented CD20-positive B-cell lymphoma as determined by the local laboratory
- fluorodeoxyglucose (FDG)-avid lymphoma (i.e., positron emission tomography (PET)-positive lymphoma)
- At least one bi-dimensionally measurable lesion
- Agreement to remain abstinent or use adequate contraception, among women or men of childbearing potential
Treatment Sites in Georgia
340 Kennestone Hospital Boulevard
Suite 200
Marietta, GA 30060
770-281-5131
www.ngoc.com
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